NCT05537818

AVPI Migraine Study

Automated Variable Pattern Insufflator Device (AVPI) for the Acute Treatment of Migraine: a Multicenter, Double-blind, Randomized, Sham-controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Nocira, LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study is designed as a multicenter, double-blind, randomized, sham-controlled trial to assess the safety and effectiveness of the Nocira AVPI Device for the acute treatment of migraine. The study is conducted in two phases in two study groups: * Phase I - initial screening of device operation in both active and sham modes in-clinic and as proctored by the investigator, and * Phase II - for further evaluation when used in the home (non-clinical) environment.

Detailed description

The study is designed as a multicenter, double-blind, randomized, sham-controlled trial to assess the safety and effectiveness of the Nocira AVPI Device for the acute treatment of migraine. The study is conducted in two phases in two study groups: * Phase I - initial screening of device operation in both active and sham modes in-clinic and as proctored by the investigator, and * Phase II - for further evaluation when used in the home (non-clinical) environment. The timing of enrollments into each group will vary between sequentially timed Phases I \& II. Group 1 subjects may participate in both Phases. Group 2 subjects participate only in Phase II. Group 1 subjects may participate for up to 90 days (45 days for each of Phases I\&II). Group 2 subjects will participate for up to 45 days.

Conditions

• Migraine

Interventions

Type	Name	Description
DEVICE	AVPI Device	The AVPI device system consists of a small, hand-held, micro-pressure pulse generator device that is operated by a hand-held mobile smartphone (iPhone®) with a downloaded software application or "app." The AVPI device is connected to an earpiece assembly that splits into two earbuds (right and left) that seat comfortably into each respective ear. 1. AVPI device for pressure regulation 2. Earpiece Assembly - a small, flexible, hollow tube that divides into right and left earpieces 3. Earbuds - replaceable, multiple sizes 4. Smartphone with the AVPI app

Timeline

• Start date: 2022-06-30
• Primary completion: 2023-12-31
• Completion: 2024-01-31
• First posted: 2022-09-13
• Last updated: 2023-05-10

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study